Last updated: 02/29/2024 18:40:45

Ancillary study on a sub-population of the chronic hepatitis B patients enrolled in the TH HBV VV-001 study to investigate the potential shedding of ChAd155-hIi-HBV after intramuscular administration

GSK study ID
207811
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
2017-002574-39
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the TH HBV VV-001 study
Trial description: This study will be performed as an ancillary study on a sub-population of the TH HBV VV-001 study including patients who will receive the highest dose of ChAd155-hIi-HBV with no co-administration. The purpose of this study is to assess the potential shedding of ChAd155-hIi-HBV after intramuscular administration.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Number of subjects with Chimpanzee Adenovirus (ChAd)155 vector Deoxyribonucleic Acid (DNA) in throat swab above the limit of detection (LOD) of the quantitative polymerase chain reaction (qPCR) assay

Timeframe: At Day 1, 3, 8, 15, 31

Number of subjects with ChAd155 vector DNA in urine above the LOD of the qPCR assay

Timeframe: At Day 1, 3, 8, 15, 31

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: ChAd155-hIi-HBV high dose formulation
  • Biological/vaccine: HBc-HBs/AS01B-4 high dose formulation
  • Biological/vaccine: Placebo
    • Enrollment:
    76
    Primary completion date:
    2022-02-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis B
    Product
    GSK3528869A
    Collaborators
    Not applicable
    Study date(s)
    October 2020 to March 2022
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    No
    • Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    • Written informed consent obtained from the patient prior to performance of any study specific procedure.
    • Patients met any exclusion criterion of the TH HBV VV-001 study (GSK study ID 204852).
    Inclusion and exclusion criteria
    Inclusion criteria:

      Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

      • Written informed consent obtained from the patient prior to performance of any study specific procedure.
      • Patients who met all inclusion criteria and were randomised to the Step B of the TH HBV VV-001 study (GSK study ID 204852).
    Exclusion criteria:

      Patients met any exclusion criterion of the TH HBV VV-001 study (GSK study ID 204852).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aachen, Nordrhein-Westfalen, Germany, 52074
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Antwerpen, Belgium, 2060
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barcelona, Spain, 08011
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Edegem, Belgium, 2650
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Frankfurt, Hessen, Germany, 60590
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hospitalet de Llobregat, Spain, 08907
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 26 Results

    Study documents

    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2022-02-03
    Actual study completion date
    2022-02-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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